Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156975
Status:
UNKNOWN
Last Update Posted:
2009-12-25
First Post:
2005-09-09
Brief Title:
Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases
Sponsor:
Arbeitsgruppe Lebermetastasen und Tumoren
Organization:
Arbeitsgruppe Lebermetastasen und Tumoren
Study Overview
Official Title:
Adjuvant Chemotherapy With Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases- Randomized Phase III Study
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary endpoint of the study is to prove the superiority of an adjuvant therapy with oxaliplatin capecitabine until the first occurrence of appearance of a tumour Occurrences in the meaning of this study are the appearance of a relapse of the tumour of metastases of a second tumour or death of any reason
Detailed Description:
Prospective randomized multi-centre open phase III study with two parallel groups of patients according to the eligibility criteria The times in both hierarchical classified endpoints will be measured as times from randomization
Patients with macroscopic complete resection of colorectal liver metastases will be randomized in
Arm A post-operative adjuvant therapy with Capecitabine Oxaliplatin over 6 months and follow-up
or
Arm B follow-up
Randomization stratification after Scores of Fong et al
number of metastases 1 vs 1
maximal diameter of the metastasis 5cm vs 5cm
disease free interval 12 months vs 12 months
CEA 200ngl vs 200 ngl in the strata 0-1 2 and 3
Patients with macroscopic complete resection of colorectal liver metastases will be randomized in
Arm A post-operative adjuvant therapy with Capecitabine Oxaliplatin over 6 months and follow-up
or
Arm B follow-up
Randomization stratification after Scores of Fong et al
number of metastases 1 vs 1
maximal diameter of the metastasis 5cm vs 5cm
disease free interval 12 months vs 12 months
CEA 200ngl vs 200 ngl in the strata 0-1 2 and 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None